Exogenous Surfactant Through Nebulizer Mask on Clinical Outcomes in Covid-19 Patients

COVID-19 Clinical Trial

— CovidSurf  

Official title:

Evaluation of the Effect of Exogenous Surfactant Through Nebulizer Mask on Clinical Outcomes in Covid-19 Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04847375
• Other study ID #: 27348
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 20, 2021
• Est. completion date: September 20, 2021

Study information

• Verified date: April 2021
• Source: Shahid Beheshti University of Medical Sciences
• Contact: Ali Dabbagh, MD
• Phone: +989121972368
• Email: alidabbagh[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Covid-19 disease is one of the most important health system challenges which is the result of the recent SARS CoV-2 virus outbreak. So far, despite the use of different types of pharmaceuticals, none has been served as a curative treatment and research is continued to find one or more effective drugs; either palliative or curative ones. One of the most important clinical problems in Covid-19 patients is lung involvement, which may causes significant sequels; leading to a main part of morbidity and/or mortality. Surfactant is one of the drugs that can have valuable effects on the lungs, both by reducing the alveolar surface tension and by exerting immunomodulatory effects. In a previous study by the same team, favorable effects were seen in intubated patients; however, the aim of this study was to evaluate the effect of exogenous nebulized surfactant in the pre-intubation stages of the disease.

Description:

Exogenous surfactant in neonates with clinical pulmonary distress syndrome has demonstrated pulmonary improvement; the latter being one of the most important applications of exogenous surfactant. In adults with underlying lung disease, especially Adult Respiratory Distress Syndrome (ARDS), there are controversial findings regarding the efficacy of surfactant. However, in a previous study, it was shown that surfactant in COVID-19 patients with pulmonary intubation improved pulmonary function and gas exchange and also, reduced patient mortality. However, none of the other repurposed drugs in COVID-19 have yet been able to prove significant effects in the treatment of patients; based on a recent study on more than 11000 COVID-19 patients (i.e. the SOLIDARITY study). Due to the significant worldwide challnege with COVID-19, many efforts have been made in this regard, but the definitive cure has not yet been obtained, and therefore, efforts are being made to find an effective method to treat the disease and improve patients' symptoms; parallel to the efforts to increase the vaccination coverage.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 20, 2021
• Est. primary completion date: July 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• age over 18 years
• definitive proof of COVID-19 infection by polymerase chain reaction (PCR) within 48 hours of hospital admission
• COVID-19 related Moderate ARDS following Berlin criteria definition with PaO2/FiO2 < 200 requiring what condition?
• Signed and dated informed consent form (ICF) by the subject or caregivers

Exclusion Criteria:

• known or high suspicion of pre-existing heart failure, unstable angina
• presence of severe shock with hemodynamic instability despite escalating vasopressors
• Severe, underlying pulmonary infection or severe pulmonary disease except for COVID-19 (COPD, pulmonary fibrosis, lung cancer, bacterial pneumonia, etc.)
• Diagnosis of pulmonary hemorrhage
• Pregnancy or lactation
• Other significant cause than ARDS to the respiratory failure
• Age less than 18
• Age more than 80
• Need for ECMO (extracorporeal membrane oxygenation) during the study
• Anticipated transfer to another hospital within 72 hours
• Known hypersensitivity to exogenous surfactant
• Current participation or participation in another study within the last month that in the opinion of the investigator would prevent enrollment for safety purposes

Related Conditions & MeSH terms

• COVID-19
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Surface-Active Agents

Intervention

Drug:
• exogenous surfactant
Nebulized Surfactant would be administered by face mask which has a nebulizer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

References & Publications (8)

Alamdari NM, Afaghi S, Rahimi FS, Tarki FE, Tavana S, Zali A, Fathi M, Besharat S, Bagheri L, Pourmotahari F, Irvani SSN, Dabbagh A, Mousavi SA. Mortality Risk Factors among Hospitalized COVID-19 Patients in a Major Referral Center in Iran. Tohoku J Exp M — View Citation

Dabbagh A, Rajaei S, Ghahremani M, Fathi M, Massoudi N, Tavana S, Fani K, Nooraee N, Malekpour Alamdari N, Besharat S, Najafi Abrandabadi A, Pirsalehi A, Khabiri Khatiri MA. The effect of surfactant on clinical outcome of patients with COVID-19 under mech — View Citation

Ghahremani M, Fathi M, Massoudi N, Tavana S, Fani K, Nooraee N, Malekpour Alamdari N, Besharat S, Naja Abrandabadi A, Pirsalehi A, Khabiri Khatiri MA, Amini Pouya M, Rajaei S, Dabbagh A. Exogenous Surfactant Versus Placebo in the Treatment of Moderate and Severe ARDS in COVID19: The Pilot Study of a Clinical Trial. DOI: https://doi.org/10.21203/rs.3.rs-136365/v1. Preprint.

INSPIRATION Investigators, Sadeghipour P, Talasaz AH, Rashidi F, Sharif-Kashani B, Beigmohammadi MT, Farrokhpour M, Sezavar SH, Payandemehr P, Dabbagh A, Moghadam KG, Jamalkhani S, Khalili H, Yadollahzadeh M, Riahi T, Rezaeifar P, Tahamtan O, Matin S, Abe — View Citation

Takian A, Raoofi A, Kazempour-Ardebili S. COVID-19 battle during the toughest sanctions against Iran. Lancet. 2020 Mar 28;395(10229):1035-1036. doi: 10.1016/S0140-6736(20)30668-1. Epub 2020 Mar 18. Erratum in: Lancet. 2020 Apr 18;395(10232):1258. — View Citation

Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8( — View Citation

Yue H, Bai X, Wang J, Yu Q, Liu W, Pu J, Wang X, Hu J, Xu D, Li X, Kang N, Li L, Lu W, Feng T, Ding L, Li X, Qi X; Gansu Provincial Medical Treatment Expert Group of COVID-19. Clinical characteristics of coronavirus disease 2019 in Gansu province, China. — View Citation

Zhang Y, Xu J, Li H, Cao B. A Novel Coronavirus (COVID-19) Outbreak: A Call for Action. Chest. 2020 Apr;157(4):e99-e101. doi: 10.1016/j.chest.2020.02.014. Epub 2020 Feb 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of tracheal intubation	the frequency of patients who will be intubated due to deteriorated pulmonary function	through study completion, an average of 1 year
Primary	rate of ICU admission	the frequency of patients who will be admitted to intensive care unit due to deteriorated pulmonary function	through study completion, an average of 1 year
Primary	lowest oxygen saturation	lowest number reading in the pulse oxymetry in one of the fingers or toes	through study completion, an average of 1 year
Secondary	30 days mortality	the mortality rate during the first 30 days after the first day of hospital admission	the first 30 days after hospital admission
Secondary	90 days mortality	the mortality rate during the first 90 days after the first day of hospital admission	the first 90 days after hospital admission